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FDA PMA

Caries detection product with drug or biologic

PMA Number: P170029 · 2025-03-03

ApplicantCalcivis Limited
Decision Date2025-03-03
PMA NumberP170029
Product CodeQJX
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeDE

Device Summary

Caries detection product with drug or biologic is the device name listed in this FDA 510(k) record. The listed applicant is Calcivis Limited. It received FDA 510(k) clearance on 2025-03-03. The device is classified under product code QJX. It was reviewed by the DE advisory panel.

Frequently Asked Questions

What is the Caries detection product with drug or biologic?

Caries detection product with drug or biologic is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Calcivis Limited.

When did Caries detection product with drug or biologic receive FDA 510(k) clearance?

The clearance date for Caries detection product with drug or biologic can be found in the official FDA records.

Who is the listed applicant for Caries detection product with drug or biologic?

The FDA 510(k) record lists Calcivis Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Caries detection product with drug or biologic?

The FDA product code for Caries detection product with drug or biologic is QJX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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